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Yutian · Medical Silicone Tubing Manufacturer
Medical Grade Silicone Tubing Manufacturer
Platinum Cured · ISO Class 8 Cleanroom · ISO 13485 Certified
Surgical Drainage Ventilator Circuits Infusion Systems BP Monitoring Disinfection Equipment
OEM/ODM Custom Solutions Free Samples with COA Fast Sampling 7–15 Days Low Tooling Cost
FDA 21 CFR 177.2600 ISO 13485 USP Class VI ISO 10993 LFGB / NSF RoHS · REACH
Medical Silicone Tubing — Engineered for Life-Critical Applications
From raw silicone to finished medical tubing, Yutian delivers quality you can trust — batch after batch.
Yutian is not just a silicone tubing supplier — we are a vertically integrated manufacturing partner. By owning the entire production chain — from silicone compounding and precision extrusion to cleanroom assembly — we maintain uncompromising control over quality, consistency, and traceability. Our mission is to provide medical device engineers with tubing they can rely on, from prototype to full-scale production.
Every tube is platinum-cured to ensure the highest purity, with no peroxide residues, no odor, and full biocompatibility. Produced in our ISO Class 8 cleanroom and certified to ISO 13485, FDA 21 CFR 177.2600, USP Class VI, and ISO 10993, our tubing meets the strictest regulatory requirements for medical devices worldwide.
Our product range includes silicone drainage tubes, ventilator circuits, infusion heating lines, BP monitor hoses, dental tubing, and radiopaque tubes — each engineered for specific clinical environments. We support custom IDs from 2mm to 50mm, rapid sampling in 7–15 days, and low-cost tooling, empowering OEM/ODM partners to accelerate development without compromising safety or performance.
↓ Explore our product series below — and find the tubing solution that fits your device perfectly.
Silicone corrugated tube for adult ventilator
We provides high-quality adult silicone spiral tubes made from premium silicone materials, featuring high flexibility and durability. These tubes are specifically designed for adult respiratory assistance devices and medical equipment. The spiral structure enhances flexibility, ensuring the tubes remain unobstructed at various angles and providing safe and comfortable use. We offer a variety of specifications to meet different medical and nursing needs.
Silicone bellows for children's ventilators
Our silicone corrugated tubes for babies and children,made from high-quality food-grade silicone material, which is safe and eco-friendly, specifically designed for infants. Its corrugated structure enhances the flexibility of the tube to accommodate various usage needs, making it widely applicable in baby feeding equipment, medical care devices, and more. With high-temperature resistance and corrosion resistance, it is suitable for long-term use, ensuring the health and safety of babies.
Medical Silicone Drainage Tubes
The silicone drainage tube is specifically designed to meet the fluid drainage needs during surgical procedures. Made from high-quality medical-grade silicone material, it ensures non-toxic and odorless operation during drainage, while providing excellent flexibility and elasticity, making it suitable for long-term use. Its efficient drainage performance is widely applied in various surgical operations, ensuring the cleanliness and recovery of postoperative wounds.
Silicone tube for disinfection equipment
Our disinfecting and flushing silicone tubes are made from selected silicone raw materials and undergo strict sterilization processes to ensure safety and sterility for single-use. These silicone tubes are widely used in the disinfection and flushing of medical equipment and infection control procedures, providing excellent temperature resistance and flexibility to ensure efficient execution of cleaning and disinfection processes.
Silicone tubing for Blood Pressure Monitor
The silicone tube for blood pressure monitors is specifically designed for blood pressure monitoring devices, made from high-quality medical-grade silicone material. It features excellent durability and precise signal transmission performance. This silicone tube is soft yet resilient, capable of adapting to frequent pressure changes, ensuring the accuracy of blood pressure data. The product is widely used in hospitals, clinics, and home blood pressure monitoring devices, providing reliable long-
Silicone Oxygen Supply Tube
The silicone oxygen supply tube is a high-performance medical-grade product specifically designed for oxygen delivery equipment. Made from premium silicone material, it offers exceptional breathability and comfort, ensuring the safety and comfort of patients during oxygen intake. This silicone tube is suitable for oxygen equipment used in hospitals and at home, providing stable oxygen delivery to ensure smooth and efficient breathing.
Physical Properties & Technical Specifications
Core material parameters and product characteristics across all medical tubing series
Common Material Specifications — All Medical Tubing Series
| Curing process | Platinum cured — no peroxide residues, no odor |
|---|---|
| Hardness range (Shore A) | 30 – 80 A (customizable per application) |
| Continuous operating temperature | -40°C to +200°C (up to +250°C optional) |
| Cleanroom manufacturing | ISO Class 8 (Class 100,000) cleanroom |
| Biocompatibility | ISO 10993 tested — non‑cytotoxic, non‑irritating, non‑sensitizing |
| Material certifications | ISO 13485, FDA 21 CFR 177.2600, USP Class VI, RoHS, REACH |
| Custom ID range | 2mm – 50mm (wall thickness 0.8 – 5.0mm) |
| Sterilization compatibility | Autoclave (121°C) · EtO · Gamma (25‑40 kGy) |
Drainage Tube
- ID 3–15mm, wall 1.5–2.5mm
- Flow rate 30–80 mL/min
- Multi‑side‑hole · anti‑blocking
- Kink‑resistant wall design
Sterile Disinfection Tube
- ID 3–20mm, wall 1.0–4.0mm
- Gamma sterilized (25‑40 kGy)
- Individual sterile barrier packaging
- SAL 10⁻⁶ · ISO 11137 compliant
Sphygmomanometer Tube
- ID 3–10mm, length 10–50cm
- Precision air holes — 5-hole standard
- Leak‑proof · stable pressure transmission
- VOC compliant · odorless
Ventilator Circuit Tube
- ID 5–15mm, working pressure 10–50 bar
- Liquid Silicone Rubber (LSR)
- 22mm / 15mm standard connectors
- Heated-wire option for humidified circuits
Infusion Heating Tube
- ID 2–8mm, power 30–100W
- Anti‑dust / anti‑static surface treatment
- ±0.5°C temperature accuracy
- Radiation‑shielded · 72+ hrs continuous use
Dental Clean Machine Tube
- ID 2–8mm, working pressure up to 80 bar
- Flow rate 5–12 L/min
- Resists disinfectants — no swelling
- Odorless · safe for oral contact
Radiopaque Tube
- ID 10–50mm, >90% light transmission
- Barium‑filled radiopaque line — X‑ray visible
- Food‑grade (FDA/LFGB) + Medical‑grade (ISO 10993)
- Double‑layer sterile packaging
Customization capabilities
Dimensions: Custom ID 2–50mm, wall thickness 0.8–5.0mm, any length. Tolerance ±0.1mm.
Shapes: Round · multi‑lumen · corrugated · custom cross‑section. Provide drawing or sample.
Materials: Standard silicone · high‑temp · flame retardant (UL94 V‑0) · antimicrobial.
Packaging: Coils · cut‑to‑length · sterile pouches · custom labeling.
Tooling fee: Low — deductible from bulk order.
Quality assurance
✔ Batch test reports: hardness (ASTM D2240), tensile strength, elongation.
✔ Biocompatibility: ISO 10993 (cytotoxicity, sensitization, irritation).
✔ Sterilization validation: gamma (25–40 kGy), EtO, autoclave reports.
✔ Cleanroom: ISO Class 8 with continuous particle monitoring.
✔ Full traceability: lot‑to‑lot, raw material to finished tube.
30+ years, true manufacturer
ISO 9001 factory with 14 extrusion lines and a 6,800㎡ facility. No middlemen – raw material compounding, extrusion, and accessory production all in‑house.
Platinum‑cured · anti‑yellowing
-40°C to +200°C continuous operation. 10,000h QUV test (ΔE＜3) – no yellowing, no cracking. Ideal for indoor/outdoor LED lighting.
Stock sizes · free sample
No MOQ for standard profiles. Free samples (shipping only). Hundreds of LED diffuser sleeves, neon strips, and covers ready to ship in 2–3 days.
Custom profiles · low tooling
Tooling from $50 to $250 (deductible). Sampling 10–15 days. Match any aluminum channel, any shape – ±0.1mm tolerance.
One‑stop accessories
Supplied with silicone end caps, stainless steel/silicone clips, and double‑sided tape. Complete solution – no need to source from multiple vendors.
RoHS · REACH · FDA
Full material compliance. Batch test reports provided. We are a semi‑finished component manufacturer – focus on extrusion quality, not finished luminaire certification.
Medical-Grade vs. Industrial-Grade — What's the Real Difference?
From material purity to cleanroom manufacturing, every detail matters when lives depend on your device.
01
What Makes a Medical-Grade Silicone Tube Different
| Yutian Medical-Grade | Ordinary Industrial-Grade | |
|---|---|---|
| Curing process | Platinum cured – no residues, no odor | Peroxide cured – residual byproducts |
| Cleanroom | ISO Class 8 (Class 100,000) cleanroom | Standard workshop (no airborne particle control) |
| Biocompatibility | ISO 10993 tested – non-cytotoxic, non-irritating | Not tested / no documentation |
| Certifications | ISO 13485 · FDA · USP Class VI · LFGB · NSF | Basic – RoHS only (if any) |
| Odor | Zero – completely odorless | Noticeable rubber/chemical smell |
| Volatiles | None – no peroxide decomposition residues | Present – residual volatiles may leach |
| Batch traceability | Full – raw material to finished tube, lot-to-lot | Limited or none |
| Sterilization compatibility | Autoclave · EtO · Gamma – all validated | Not recommended – risk of degradation |
| Documentation | COA + Biocompatibility report + Sterilization validation | COA only (if available) |
02
Vertically Integrated Manufacturer vs. Trader / Small Factory
| Yutian (Vertically Integrated) | Typical Trader | Small Factory | |
|---|---|---|---|
| Raw material control | ✔ In-house (Guilin Yutian) | ✘ Outsourced | ✘ Outsourced |
| Compounding & formulation | ✔ In-house (Dongguan Huahong) | ✘ Outsourced | ⚠ Basic only |
| Cleanroom manufacturing | ✔ ISO Class 8 | ✘ None | ✘ None |
| Medical certifications | ✔ ISO 13485 · FDA · USP | ✘ None | ✘ None |
| Daily production capacity | 300,000 meters | Inconsistent | Limited |
| Custom ID range | 2–50mm (any) | Stock sizes only | Limited |
| Sample lead time | 7–15 days | Depends on supplier | 15–30 days |
| Supply stability | ✔ Predictable · Reliable | ⚠ Volatile | ⚠ Volatile |
03
Silicone vs. Alternative Materials for Medical Tubing
| Silicone (Yutian Medical-Grade) | PVC | EPDM | |
|---|---|---|---|
| Medical-grade certification | ✔ FDA · ISO 10993 · USP Class VI | ✘ Not recommended | ✘ Not recommended |
| Operating temperature range | -40°C to +200°C | -10°C to +60°C | -20°C to +120°C |
| Platinum cured / odorless | ✔ Yes – completely odorless | ✘ Strong plastic odor | ⚠ Rubber odor |
| Biocompatibility | ✔ ISO 10993 compliant | ✘ Not suitable | ✘ Not suitable |
| Low-temperature flexibility | ✔ Excellent – stays soft | ✘ Becomes brittle | ⚠ Moderate |
| Chemical resistance | ✔ Excellent | ⚠ Moderate | ✔ Good |
| Service life | 5+ years | 1–2 years | 2–3 years |
Ready to Upgrade to Medical-Grade Silicone Tubing?
Free samples available · ISO 13485, FDA certified · Custom sizes, 7–15 day sampling · Low tooling cost
✔ Free samples (stock sizes) ✔ ISO 13485 · FDA · USP Class VI certified ✔ Custom ID 2–50mm · 7–15 day sampling ✔ Low tooling cost · Full documentation
First contact – trade show sample
The customer picked up our brochure at a lighting exhibition, ordered a sample of a standard LED silicone diffuser, and placed his first small order. Satisfied with the quality, he decided to develop his own custom profile.
Drawing #1 – dark shadows on both sides
He sent his initial design. The LED channel walls were too thick, blocking light from reaching the edges. The result: dark shadows on both sides. He insisted on keeping his own LED strip, so we had to solve it through the diffuser.
Drawing #2 – LED spots (visible dots)
After thinning the walls, the shadows disappeared – but now LED spots appeared on the surface. The light was too concentrated, showing every single LED chip.
Drawing #3 – weak brightness
We tried increasing diffusion to hide the spots, but the overall light output became too dim. The customer was frustrated – three rounds, three different problems.
The breakthrough – modifying the silicone formulation
Our engineers realized that simply adjusting wall thickness was not enough. The real solution lay in the silicone material itself. We reformulated the compound, adding optimized diffusion additives to increase light scattering while maintaining high transmittance. After multiple trials, we found the perfect balance: no LED spots, no shadows, and full brightness – all while keeping his original LED strip unchanged.
Complete solution – end caps, clips & installation know‑how
We also developed matching end caps and mounting clips for his custom profile – a true one‑stop service. We taught him how to make the silicone diffuser dust‑resistant and how to thread long LED strips into long silicone tubes without damage.
Long‑term partnership – 4 years and still growing
He has been a loyal customer for over four years. He shares real‑world needs from his European clients, and together we co‑develop new products. That’s how we grow – not as a vendor, but as a partner.
Frequently Asked Questions
Quick answers to the most common questions from medical device engineers, procurement professionals, and quality managers — all in one place.
Quality & Compliance
Our medical silicone tubing is certified to ISO 13485 (medical device quality management), FDA 21 CFR 177.2600 (food and medical-grade material), USP Class VI (biocompatibility), LFGB (German food contact), NSF, RoHS, and REACH. Full ISO 10993 biocompatibility test reports are available upon request.
Yes. All our medical-grade tubing is tested per ISO 10993 for cytotoxicity, sensitization, and irritation — the three core biocompatibility endpoints for medical devices. Reports are available for each batch or lot upon request.
Platinum-cured silicone uses a noble metal catalyst that leaves no harmful residues, no odor, and no volatile compounds — making it the preferred choice for medical and food-contact applications. Peroxide-cured silicone leaves residual byproducts that can leach out over time, posing potential contamination risks. Every Yutian medical tube is platinum-cured.
Customization & Manufacturing
Absolutely. We support custom ID from 2mm to 50mm, wall thickness from 0.8mm to 5.0mm, and any length. We can also produce multi-lumen, corrugated, and custom cross-section profiles to your exact drawing or sample. Low tooling cost — deductible from bulk orders.
MOQ is flexible and depends on the complexity of the product (size, material, cross-section). We are happy to accommodate small trial quantities for new projects — contact us with your specifications for a tailored quote.
Yes. We operate an ISO Class 8 (Class 100,000) cleanroom with continuous particle monitoring — ensuring a contamination-free environment essential for medical device components.
Tooling cost for custom extrusion dies is typically low compared to injection molds. For standard profiles, we may already have existing tooling — no extra cost. For custom designs, the tooling fee is deductible from your first bulk order. Contact us for a specific quote.
Samples & Delivery
Yes — free samples are available for stock sizes (shipping cost applies). For custom samples, we charge a small tooling fee (deductible). Each sample ships with a COA test report so you can verify material properties before ordering.
Stock samples: 3–5 days. Custom samples: 7–15 days (depending on complexity). Mass production: 10–15 days after sample approval. Expedited options are available for urgent projects — just ask.
Yes. Every shipment includes a COA (Certificate of Analysis) with batch-specific test results for hardness, tensile strength, and elongation. We can also provide ISO 10993 biocompatibility reports, sterilization validation reports, and material safety data sheets upon request — full documentation for your regulatory file.
Technical & Applications
Our medical silicone tubing is compatible with steam autoclaving (121°C), ethylene oxide (EtO), and gamma irradiation (25–40 kGy). We provide validation reports for each method upon request. For specific applications, our team can recommend the optimal sterilization approach.
Our tubing is already used in surgical drainage, respiratory ventilation, infusion therapy, blood pressure monitoring, dental equipment, and disinfection systems. If you have a specific application in mind — we've likely worked with it. Contact us with your requirements, and our engineering team will evaluate the best material and design for your device.
Medical-Grade Silicone Tubing — Engineered for Precision, Backed by Integrity.
From the operating room to the home care setting, Yutian's medical silicone tubing delivers the performance, purity, and consistency that healthcare demands. Every tube is platinum-cured, produced in an ISO Class 8 cleanroom, and certified to ISO 13485, FDA, and USP Class VI — because when patient outcomes depend on your device, there's no room for compromise.
Whether you're developing a new medical device or optimizing an existing supply chain, we're here to help. Our engineering team works alongside you — from material selection and prototyping to full-scale production and sterile packaging — ensuring your tubing solution is delivered right, on time, every time.
Trust Yutian. Trust the difference.
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with products that are incredibly strong, remarkably flexible, and simple to use.”
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As a leading silicone products manufacturer based in China, Yutian offers a diverse range of customized silicone products for various industries. With our state-of-the-art facilities, including 8x40-meter assembly lines, on-site 5S management, and stringent quality control measures, we ensure top-notch production standards.
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